Introduction

Aligned Elements is a Medical Device ALM built to capture and manage Design Control Items and the processes needed to provide adequate traceability. It is intended as a support system for medical device manufacturers and suppliers.

About Aligned Elements

Aligned Elements is a Medical Device Application Lifecycle Management system to help you create and maintain your medical device development documentation.

Aligned Elements is created to support the documentation standards for highly regulated markets. This solution includes a number of different function areas used for all parts of the DHF Management, all merged into one:

• Design Input and Design Output management: structure your project documentation to make the right decisions and the right next steps.

• Risk Management: manage your risk assessments and ensure that risks are sufficiently mitigated.

• Verification and Validation Management: implement and manage your Verification and Validation efforts to ensure that the product corresponds to the planned design.

• Document management: help you keep your document versioned and under control and features tight integration with Microsoft Word automating some documentation tasks.

• Version manager: automatically keeps an audit trail of all your changes in your project. Identify the status at different milestones.

• Issue management: report all your known errors or to-dos and link to your existing documentation.

It also supports an instant gap analysis where you continuously can verify what inconsistencies you have in your project (before someone else does).

Disclaimer

This user manual is solely intended for user guidance and does not imply any legally binding description of functionality.

Since Aligned Elements does not prescribe any specific process, the scope of the manual excludes any development process related issues. This is expected to be provided by the customer’s own organization.